Hoerger Michael
a Tulane Cancer Center and Departments of Psychology and Psychiatry , Tulane University , New Orleans , Louisiana , USA.
Death Stud. 2016;40(2):113-20. doi: 10.1080/07481187.2015.1077356. Epub 2015 Aug 27.
The U.S. Food and Drug Administration's Expanded Access program allows patients with life-threatening diagnoses, such as advanced cancer, to use experimental medications without participating in clinical research (colloquially, "Compassionate Use"). Sixteen U.S. states recently passed "right-to-try" legislation aimed at promoting Expanded Access. Acknowledging popular support, Expanded Access could undermine clinical trials that benefit public health. Moreover, existing norms in oncologic care, for example, often lead patients to pursue intense treatments near the end of life, at the expense of palliation, and improved communication about the risks and benefits of Expanded Access would more often discourage its use.
美国食品药品监督管理局的扩大使用项目允许患有晚期癌症等危及生命疾病的患者使用试验性药物,而无需参与临床研究(通俗地说,即“同情用药”)。美国16个州最近通过了旨在推动扩大使用的“尝试权”立法。尽管得到了民众支持,但扩大使用可能会破坏有益于公众健康的临床试验。此外,例如肿瘤护理方面的现有规范常常导致患者在生命末期寻求积极治疗,却牺牲了姑息治疗,而关于扩大使用的风险和益处的更好沟通往往会减少其使用。